Ebola Zaire vaccine (Rx)

Brand and Other Names:Ervebo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, suspension

  • 1mL (single-dose vial)

Immunization Against Ebola Zaire Virus

Indicated for prevention of disease caused by Zaire ebolavirus

1 mL IM once

ACIP recommendations

  • Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following people who:
  1. Are responding to an outbreak of Ebola virus disease; or
  2. Work as healthcare personnel at federally-designated Ebola Treatment Centers (ETCs) in the U.S.; or
  3. Work as laboratorians or other staff at biosafety-level 4 facilities in the U.S.

Dosing Considerations

Limitations of use

  • Duration of protection conferred by vaccine is unknown
  • Does not protect against other species of Ebolavirus or Marburgvirus
  • Effectiveness of vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown

<18 years: Safety and efficacy not established

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Interactions

Interaction Checker

and Ebola Zaire vaccine

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site pain (34-69.5%)

            Headache (36.9%)

            Feverishness (34.3%)

            Muscle pain (32.5%)

            Fatigue (18.5%)

            Joint pain (17.9%)

            Injection site swelling (16.5%)

            Injection site redness (11.9%)

            1-10%

            Nausea (8%)

            Joint pain/tenderness (7%)

            Arthritis (0.8-4.7%)

            Rash (3.6-3.8%)

            Abnormal sweating (3.2%)

            Local reactions (eg, redness, swelling) (1.8%)

            Vesicular lesions (1.5%)

            <1%

            Arthropathy (joint redness/warmth) (0.6%)

            Joint swelling (0.4%)

            Joint stiffness (0.4%)

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            Warnings

            Contraindications

            Hypersensitivity to any component of the vaccine, including rice protein

            Cautions

            There were 2 reports of anaphylaxis; monitor for signs and symptoms of hypersensitivity reactions following vaccination; appropriate medical treatment and supervision must be available in case of an anaphylactic event following administration

            Vaccination may not protect all individuals; vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission

            Safety and effectiveness have not been assessed in immunocompromised individuals; weigh the risk of vaccination in immunocompromised individuals against the risk of disease due to Zaire ebolavirus

            Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility

            Drug interaction overview

            • Interference with laboratory tests
              • Following vaccination, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens
              • GP-based testing may have limited diagnostic value during period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine
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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women, and human data available from clinical trials are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy

            Consider the woman’s risk of exposure to Zaire ebolavirus before vaccination

            Clinical considerations

            • Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus
            • Majority of such pregnancies end in miscarriage or stillbirth
            • In pregnancies where live birth does occur, neonates generally do not survive
            • Potential for transmission of the vaccine virus from mother to the fetus/neonate is unknown

            Lactation

            Human data are not available to assess the effects on milk production, its presence in breast milk, or its effects on the breastfed child

            Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition

            For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant vesicular stomatitis virus-Zaire ebolavirus (rVSV-ZEBOV; V920) is a replication-competent vaccine

            Genetically engineered to express a glycoprotein from the Zaire ebolavirus to provoke a neutralizing immune response to the Ebola virus

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            Administration

            IM Preparation

            Thaw vial at room temperature until no visible ice is present; do not thaw vial in a refrigerator

            Gently invert vial several times

            Visually inspect for particulate matter and discoloration before use, vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible

            Use the vaccine immediately after thawing

            Withdraw 1-mL dose from vial using a sterile needle and sterile syringe

            IM Administration

            Administer a 1-mL dose IM, preferably in the deltoid area of the nondominant arm

            Discard unused portion

            Storage

            Unopened vials: Freeze at -80 to -60ºC (-112 to -76ºF) in the original carton to protect from light; do not thaw the vial in a refrigerator

            Thawed vials: If not used immediately, refrigerate at 2-8ºC (35.6-46.4ºF) for a total time of no more than 2 weeks and at room temperature (up to 25ºC; 77ºF) for a total time of no more than 4 hr

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.